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FDA 510(k)

React 68 Catheter

K-Number: K180715 · 2018-07-04

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2018-07-04
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

React 68 Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2018-07-04 under 510(k) number K180715. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the React 68 Catheter?

React 68 Catheter is a medical device that received FDA 510(k) clearance on 2018-07-04. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K180715.

When did React 68 Catheter receive FDA 510(k) clearance?

React 68 Catheter received FDA 510(k) clearance on 2018-07-04, under 510(k) number K180715.

Who is the listed applicant for React 68 Catheter?

The FDA 510(k) record lists Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for React 68 Catheter?

The FDA product code for React 68 Catheter is DQY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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